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Operator
Operator
Good afternoon and welcome to our second-quarter 2024 earnings call. As a reminder, this call is being recorded. (Operator Instructions)
下午好,歡迎參加我們的 2024 年第二季財報電話會議。謹此提醒,此通話正在錄音中。(操作員說明)
A webcast replay of today's conference call will be available on our website at lanternpharma.com shortly after the call. We issued a press release after market close today, summarizing our financial results and progress across the companyr for the second quarter ended June 30, 2024. A copy of this release is available through our website at lanternpharma.com, where you will also find a link to the slides management will be referencing on today's call.
電話會議結束後不久,我們將在我們的網站 Lanternpharma.com 上提供今天電話會議的網路廣播重播。今天收盤後,我們發布了一份新聞稿,總結了截至 2024 年 6 月 30 日的第二季度的財務業績和整個公司的進展。新聞稿的副本可透過我們的網站 Lanternpharma.com 取得,您還可以在其中找到指向今天電話會議中將引用的幻燈片管理層的連結。
We would like to remind everyone that remarks about future expectations, performance, estimates, and prospects constitute forward-looking statements for purposes of Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Lantern Pharma cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated.
我們想提醒大家,有關未來預期、績效、估計和前景的言論構成前瞻性陳述,符合 1995 年《私人證券訴訟改革法案》中的安全港條款。Lantern Pharma 警告稱,這些前瞻性聲明存在風險和不確定性,可能導致實際結果與預期有重大差異。
A number of factors could cause actual results to differ materially from those indicated by forward-looking statements, including results of clinical trials and the impact of competition. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements can be found in our annual report on Form 10-K for the year ended December 31, 2023, which is on file with the SEC and available on our website.
許多因素可能導致實際結果與前瞻性陳述所示的結果有重大差異,包括臨床試驗結果和競爭的影響。有關可能導致實際結果與前瞻性陳述中的結果存在重大差異的因素的更多信息,請參閱我們截至 2023 年 12 月 31 日的 10-K 表格年度報告,該報告已向 SEC 備案並可供查閱在我們的網站上。
Forward-looking statements made on this conference call are as of today, August 8, 2024, and Lantern Pharma does not intend to update any of these forward-looking statements to reflect events from circumstances that occur after today, unless required by law.
本次電話會議中所做的前瞻性陳述截至今天,即 2024 年 8 月 8 日,除非法律要求,否則 Lantern Pharma 不打算更新任何這些前瞻性聲明以反映今天之後發生的事件。
The webcast replay of the conference call and webinar will be available on Lantern's website.
電話會議和網路研討會的網路直播重播將在 Lantern 網站上提供。
On today's webcast, we have Lantern Pharma's CEO, Panna Sharma and members of management. Panna will start things off with introductions and an overview of Lantern's strategy and business model and highlight recent achievements in our operations, followed by discussion of our financial results and a discussion of the Harmonic clinical trial results.
在今天的網路廣播中,我們有 Lantern Pharma 的執行長 Panna Sharma 和管理層成員。Panna 將首先介紹和概述 Lantern 的策略和商業模式,並重點介紹我們最近在營運中的成就,然後討論我們的財務表現和 Harmonic 臨床試驗結果。
I'd now like to turn the call over to Panna Sharma, President and CEO of Lantern Pharma. Panna, please go ahead.
我現在想將電話轉給 Lantern Pharma 總裁兼執行長 Panna Sharma。潘娜,請繼續。
Panna Sharma - President, Chief Executive Officer, Director
Panna Sharma - President, Chief Executive Officer, Director
Good afternoon, and thank you, everyone, for joining us to hear about our incredibly productive second quarter of 2024.
下午好,感謝大家與我們一起聆聽我們在 2024 年第二季度取得的令人難以置信的成果。
Today, on the call, I have our CFO, David Margrave; and also our Head VP of Clinical Development, Dr. Reggie Ewesuedo. I'll begin the call by discussing generally the quarter and then hand it over to David to talk about the financials. And then Reggie and I will discuss the progress with our LP-300 clinical trial. As many of you have heard me say in the past, computational and AI-driven approaches are increasing their presence and usage at both large and emerging pharma companies for all facets of drug discovery, chemistry, biology, even now manufacturing and patient selection.
今天,我們的財務長 David Margrave 參加了電話會議。還有我們的臨床開發首席副總裁 Reggie Ewesuedo 博士。我將在電話會議開始時一般性地討論本季度的情況,然後將其交給 David 討論財務狀況。然後 Reggie 和我將討論 LP-300 臨床試驗的進展。正如你們許多人過去聽我說過的那樣,計算和人工智慧驅動的方法正在增加其在大型和新興製藥公司中的存在和使用,涉及藥物發現、化學、生物學,甚至現在的製造和患者選擇的各個方面。
And at no time has this been more evident than today where every facet of pharma development from molecular design to disease modeling is being rethought as a result of the widespread availability of computational capabilities, high-quality data, and improved automation. Our company's leadership in the innovative use of AI and machine learning to transform costs and timelines, the development of precision oncology therapies should yield significant returns for investors and patients as our industry matures and adopts an AI-centric data-first approach to drug development.
這在任何時候都比今天更加明顯,由於計算能力、高品質數據和自動化程度的提高,從分子設計到疾病建模的製藥開發的各個方面都在被重新考慮。隨著我們行業的成熟並採用以人工智慧為中心的數據優先方法進行藥物開發,我們公司在創新利用人工智慧和機器學習來改變成本和時間表方面的領導地位,精準腫瘤治療的開發應該為投資者和患者帶來可觀的回報。
Today, we have three active clinical trials with an additional ADC-based preclinical program and a very active approach in identifying and validating combination approaches with our drugs. With our RADR AI platform, which is at the forefront of cancer drug development, we expect more activity and opportunities where we can continue to use our AI as currency for collaborations, partnerships, and co-development opportunities.
如今,我們開展了三項活躍的臨床試驗,其中包括一項基於 ADC 的臨床前計劃,以及一種非常積極的方法來識別和驗證我們藥物的組合方法。憑藉我們處於癌症藥物開發前沿的 RADR AI 平台,我們期待更多的活動和機會,我們可以繼續使用我們的 AI 作為合作、夥伴關係和共同開發機會的貨幣。
We also planned to continue driving the ongoing innovation in our portfolio of drug candidates and drug programs. This past quarter was a particularly busy one for Lantern and especially with our clinical operations team as we had a notable initial readout in our Phase 2 Harmonic clinical trial, where we saw a preliminary but interesting 86% clinical benefit rate in the lead-in patient cohort.
我們還計劃繼續推動我們的候選藥物和藥物項目組合的持續創新。過去的一個季度對Lantern 來說特別忙碌,尤其是我們的臨床營運團隊,因為我們在2 期Harmonic 臨床試驗中獲得了顯著的初步讀數,我們在引入患者中看到了初步但有趣的86% 臨床受益率隊列。
Our intellectual property also continues to grow globally, and we were awarded a very important patent in Japan directed at our LP-284 drug candidate, which is focused on the treatment of B-cell cancers.
我們的智慧財產權也在全球範圍內不斷增長,我們在日本獲得了一項非常重要的專利,該專利針對的是我們的 LP-284 候選藥物,該藥物專注於 B 細胞癌症的治療。
So going back to our clinical trials, we have also dosed over 40 patients now in our LP-184 and LP-284 clinical trials. These are trials that are in Phase 1a and they have not yet seen any dose-limiting toxicities or events, which we will discuss more in depth later in the call.
回到我們的臨床試驗,我們現在也在 LP-184 和 LP-284 臨床試驗中對 40 多名患者進行了給藥。這些試驗處於 1a 期,尚未發現任何劑量限制性毒性或事件,我們將在稍後的電話會議中更深入地討論。
Our team has also achieved significant advancement towards a key milestone in the development of a molecular diagnostic for use with our drug candidate, LP-184. We expect to potentially use this diagnostic to improve patient selection and stratification and the novel biomarker is PTGR1, one that we validated extensively both in the lab but also in silico. It was identified through a number of in silico AI-driven screens.
我們的團隊還在開發與我們的候選藥物 LP-184 一起使用的分子診斷方面取得了重大進展,邁向了一個關鍵里程碑。我們希望能夠利用這種診斷來改善患者選擇和分層,而新型生物標記是 PTGR1,我們在實驗室和電腦中都對其進行了廣泛驗證。它是透過許多由電腦人工智慧驅動的螢幕來識別的。
We also launched a very important strategic drug development collaboration using our AI platform, Oregon Therapeutics to optimize the development of our first-in-class drug candidate, XCE853, a potent inhibitor of cancer metabolism, which we believe can have impact across multiple cancers and has a unique mechanism of action involving proteotoxicity.
我們也利用我們的人工智慧平台Oregon Therapeutics 啟動了一項非常重要的策略性藥物開發合作,以優化我們一流的候選藥物XCE853 的開發,XCE853 是一種有效的癌症代謝抑制劑,我們相信它可以對多種癌症和癌症產生影響。
With Starlight Therapeutics, our wholly owned subsidiary focused on CNS and brain cancers, we've advanced towards initiating site selection and feasibility for a Phase 1b/Phase 2 trial in recurrent GBM with drug candidate STAR-001. Our team also successfully launched Webinar Wednesdays, our webinar series focusing on the areas of artificial intelligence, oncology drug development, and leveraging our relationships with leading physician, scientists, and our collaborators.
透過我們專注於中樞神經系統和腦癌的全資子公司 Starlight Therapeutics,我們已著手啟動候選藥物 STAR-001 復發性 GBM 1b 期/2 期試驗的選址和可行性。我們的團隊也成功推出了周三網路研討會,這是我們的網路研討會系列,重點關注人工智慧、腫瘤藥物開發領域,並利用我們與領先醫生、科學家和合作者的關係。
We also closed the quarter with approximately $33.3 million in cash, cash equivalents, and marketable securities, which our CFO will talk about later in today's call. In many of the initial observations made with the help of RADR are now being witnessed in the clinic, as many of you know. RADR has guided the rapid and efficient development of three AI-guided drugs into clinical trials over the past several years at a pace and cost that has traditionally been unheard of in our industry.
本季結束時,我們還擁有約 3,330 萬美元的現金、現金等價物和有價證券,我們的財務長將在今天的電話會議稍後討論這些問題。正如你們許多人所知,許多在 RADR 幫助下進行的初步觀察現在正在診所中得到證實。在過去的幾年裡,RADR 指導了三種人工智慧引導藥物的快速高效開發進入臨床試驗,其速度和成本在我們行業中是聞所未聞的。
Let me walk you through some highlights from our AI-powered pipeline, which is again currently in the clinic, before I talk about other aspects of our business.
在談論我們業務的其他方面之前,讓我先向您介紹我們的人工智慧驅動管道的一些亮點,該管道目前再次處於臨床階段。
Specifically with LP-184, our team and many clinicians are particularly excited about and interested in these programs for first-in-human synthetically lethal drug candidates that are acylfulvene's LP-184 and LP-284. So far, seven cohorts of patients, comprised of dose levels one through seven had been enrolled in escalating doses in the ongoing Phase 1a clinical trial for LP-184. This is a first-in-human Phase 1 trial across multiple solid tumor indications that are advanced and refractory to the existing standard of care. Very exciting for us as there have been no observed dose limiting toxicities to date.
特別是 LP-184,我們的團隊和許多臨床醫生對這些針對人類首個合成致死候選藥物(酰基富烯的 LP-184 和 LP-284)的計畫特別興奮和感興趣。到目前為止,已有 7 組患者(劑量水準為 1 至 7 級)參加了正在進行的 LP-184 1a 期臨床試驗,以逐步增加劑量。這是一項針對多種實體瘤適應症的首次人體 1 期試驗,這些適應症對於現有的護理標準來說是晚期且難治的。對我們來說非常令人興奮,因為迄今為止尚未觀察到劑量限制毒性。
Now we're at the point now in the trial where we expect to reach a dosage level in the coming cohorts where therapeutic concentrations of the drug should be attainable based on our pharmacokinetic and pharmacodynamic analysis. So mouthful, but all that means is we should start potentially seeing benefit in patients at these cohorts going forward.
現在,我們正處於試驗階段,根據我們的藥物動力學和藥效學分析,我們預計在未來的隊列中能夠達到藥物的治療濃度。聽起來很拗口,但這意味著我們應該開始看到這些隊列中的患者未來可能會受益。
The trial is actively enrolling patients across multiple US centers. These patients are relapsed. They're refractory to all existing standard of care, typically. And they have advanced solid tumors such as pancreatic cancer, glioblastoma, triple-negative breast cancer, and also now increasingly with solid tumor types focused on DNA damage response deficiencies.
該試驗正在美國多個中心積極招募患者。這些患者病情復發。通常,它們無法適應所有現有的護理標準。他們患有晚期實體瘤,如胰腺癌、膠質母細胞瘤、三陰性乳腺癌,現在越來越多的實體瘤類型集中於 DNA 損傷反應缺陷。
The company believes that enrollment should be complete this year and on track for an initial readout of safety and molecular correlation data by the close of the year. The dosage and safety data obtained in the Phase 1a trial for LP-184 are expected to be used to advance the central nervous system indications for the Phase 1b and Phase 2 trial to be sponsored by Lantern's wholly owned subsidiary , Starlight, as well as other later-phase trials in select tumors that have shown superior responsiveness to 184 and also meet our genomically guided criteria.
該公司認為,註冊工作將於今年完成,並預計在年底前初步讀出安全性和分子相關性數據。LP-184 1a 期試驗中獲得的劑量和安全性數據預計將用於推進 1b 期和 2 期試驗的中樞神經系統適應症,該試驗由 Lantern 的全資子公司 Starlight 以及其他公司贊助。的腫瘤中進行的後期試驗顯示出對184 的卓越反應性,並且也符合我們的基因組指導標準。
AI and preclinical studies are also ongoing to further refine drug combination studies. Many of you saw the press release from yesterday, and this press release supports -- at least, tend to support the improvement to durability and response with other FDA approved drugs. Specifically, we published on PARP inhibitors earlier this quarter, and yesterday, in immune checkpoint inhibitors. These are two very exciting areas where the combination of our drug with these -- some of the existing approved agents, many of which are multibillion-dollar drugs, actually, we feel can benefit patients in certain solid tumors like triple-negative breast cancer or others that have DNA repair deficiency.
人工智慧和臨床前研究也在進行中,以進一步完善藥物組合研究。你們中的許多人都看到了昨天的新聞稿,該新聞稿支持——至少傾向於支持 FDA 批准的其他藥物的耐久性和反應性的改善。具體來說,我們在本季早些時候發表了有關 PARP 抑制劑的文章,昨天又發表了有關免疫檢查點抑制劑的文章。這是兩個非常令人興奮的領域,我們的藥物與這些藥物的結合——一些現有的已批准藥物,其中許多是數十億美元的藥物,實際上,我們認為可以使某些實體瘤的患者受益,例如三陰性乳癌或其他有 DNA 修復缺陷的人。
Globally, the aggregate annual market potential for LP-184's target indications we believe is in excess of $10 billion to $12 billion, consisting of about $4 billion to $5 billion in CNS cancers and $7 billion to $8 billion for other solid tumors. For LP-284, the third cohort of patients are being dosed and no dose-limiting toxicities have been observed in this Phase 1a trial, and we expect to open additional sites throughout the quarter with the potential to advance to Phase 1b and Phase 2 with the close of this year or early 2025.
在全球範圍內,我們認為 LP-184 目標適應症的年度市場潛力總額超過 100 億至 120 億美元,其中中樞神經系統癌症約 40 億至 50 億美元,其他實體瘤約 70 億至 80 億美元。對於 LP-284,第三組患者正在接受給藥,在該 1a 期試驗中尚未觀察到劑量限制性毒性,我們預計在整個季度開放更多站點,有可能推進到 1b 期和 2 期今年年底或2025 年初。
LP-284 has shown nanomolar potency across multiple published in-vitro and in-vivo studies, including mantle cell, double-hit, and other non-Hodgkin's lymphomas, and especially, those with DNA damage response deficiency. We published in cancers that have compromised functioning of ATM due to mutations or deletions.
LP-284 在多項已發表的體外和體內研究中顯示出納摩爾效力,包括套細胞淋巴瘤、雙重打擊淋巴瘤和其他非霍奇金淋巴瘤,特別是那些具有 DNA 損傷反應缺陷的淋巴瘤。我們發表了由於突變或缺失而損害 ATM 功能的癌症。
Now nearly, all MCL double-hits high-grade B-cell lymphoma patients relapsed from the current standard of care agents. And there's this urgent and unmet need for novel improved therapeutics for these patients. We believe the annual market potential in this group is in excess of $3 billion. We've also begun a review of some notable mechanism of action that we observe in LP-284. And we think we can actually leverage those in other diseases and conditions. Lantern expects to review those preclinical studies and findings later this quarter.
現在,幾乎所有 MCL 雙重打擊高級別 B 細胞淋巴瘤患者都在採用目前標準治療藥物後復發。這些患者迫切需要改進的新型療法,但這項需求尚未得到滿足。我們相信該類別的年市場潛力超過 30 億美元。我們也開始檢視我們在 LP-284 中觀察到的一些值得注意的作用機制。我們認為我們實際上可以利用這些來治療其他疾病和病症。Lantern 預計將在本季稍後審查這些臨床前研究和結果。
Our current enrollment efforts are focused on cancer patients with tumors that have what's called DNA damage repair deficiency. They've been observed to have higher sensitivity to 184 and even in some cases, 284. So DDR genomic alterations are of interest for these trials and we may consider other genomic alterations based on other emerging data.
我們目前的招募工作主要集中在患有所謂 DNA 損傷修復缺陷的腫瘤的癌症患者。據觀察,他們對 184 甚至在某些情況下對 284 具有更高的敏感性。因此,DDR 基因組改變對這些試驗很有意義,我們可能會根據其他新出現的數據考慮其他基因組變化。
We also continue to make significant progress in the launch of our clinical-stage CNS and brain cancer-focused subsidiary, Starlight Therapeutics. This is a company that has been largely developed as a result of big data. Because of the billions of data points that we had in our system, we used AI methods to look at specific indications, validated those computationally, optimize our understanding, and then took them into studies -- wet lab studies with animals and mice and PDX models. And now, we're actually at a point where we can start taking these indications into the clinic.
我們也在推出專注於中樞神經系統和腦癌臨床階段的子公司 Starlight Therapeutics 方面繼續取得重大進展。這是一家很大程度上依靠大數據而發展起來的公司。由於我們的系統中有數十億個數據點,我們使用人工智慧方法來查看特定的適應症,透過計算驗證這些適應症,優化我們的理解,然後將它們納入研究中——對動物、小鼠和PDX 模型進行濕實驗室研究。現在,我們實際上已經到了可以開始將這些適應症引入臨床的階段。
Notably, we've also actually started site selection for the upcoming Phase 1b and Phase 2 trials, especially in recurrent IDH wild-type high-grade gliomas like GBM. This is very different than the most recent approval, which was IDH mutant. So if you've not reviewed our webinar Wednesday on Starlight with Dr. Marc Chamberlain, I would definitely urge you all to listen to the webinars where we providing detail, the timing and focus of the trials that we anticipate launching with Starlight.
值得注意的是,我們實際上也開始為即將到來的 1b 期和 2 期試驗進行選址,特別是在復發性 IDH 野生型高級別膠質瘤(如 GBM)中。這與最近批准的 IDH 突變體有很大不同。因此,如果您還沒有觀看我們週三與Marc Chamberlain 博士在Starlight 上舉行的網絡研討會,我強烈建議大家收聽網絡研討會,我們將在其中提供我們預計將在Starlight 上啟動的試驗的詳細信息、時間安排和重點。
Now the golden age of AI in medicine is just beginning as witnessed even today by -- a discussion of today's merger among two big AI companies, Recursion in the US and Exscientia in the UK, and there is a need to really use large scale, highly available computing power, massive data storage, and the tremendous high-def biology that's available today, and that is what we're at the forefront of.
現在,醫學人工智慧的黃金時代才剛開始,今天就見證了這一點——今天討論了兩家大型人工智慧公司(美國的 Recursion 和英國的 Exscientia)的合併,並且需要真正大規模使用、高可用的運算能力、海量資料儲存以及當今可用的巨大高清生物學,而這正是我們處於最前沿的。
But we're also, at Lantern's way, we're harnessing those capabilities in a way we believe is much more efficient. We want to harness these capabilities in this emerging tech bio industry and be a long-term leader, not only where we create massive value for patients and also continue to drive innovation. But we're also thoughtful about the economics of cancer drug development. It's one of the first reasons many of us joined this company. We wanted to not only make drugs faster, but we also wanted to make them smarter and cheaper.
但我們也以 Lantern 的方式,以我們認為更有效的方式利用這些功能。我們希望在這個新興的科技生物產業中利用這些能力,成為長期領導者,不僅為患者創造巨大價值,而且繼續推動創新。但我們也對癌症藥物開發的經濟學進行了深思熟慮。這是我們許多人加入這家公司的首要原因之一。我們不僅希望更快地生產藥物,而且還希望使其更聰明、更便宜。
And Lantern is among the leaders in this transformation of the pace, the risk, and the cost of oncology drug discovery and development. This transformation, as I promised, not only to make medicines faster, cheaper, and with increased precision for patients, but also to help change the direction of R&D productivity and output in cancer -- in the cancer biopharma industry.
Lantern 是腫瘤藥物發現和開發的速度、風險和成本轉變的領導者之一。正如我所承諾的那樣,這種轉變不僅可以使藥物更快、更便宜、為患者提供更高的精確度,而且有助於改變癌症生物製藥行業的研發生產力和產出方向。
Now let's turn to our -- focus to our financial updates and highlights with David. I'll now turn the call over to our CFO, David Margrave who will provide an overview of our quarter's financial results. David?
現在讓我們專注於大衛的財務更新和亮點。我現在將把電話轉給我們的財務長 David Margrave,他將概述我們季度的財務表現。大衛?
David Margrave - Chief Financial Officer, Secretary
David Margrave - Chief Financial Officer, Secretary
Thank you, Panna, and good afternoon, everyone.
謝謝潘納,大家下午好。
I will now share some financial highlights from our second quarter ended June 30, 2024. We recorded a net loss of approximately $4.96 million for the second quarter of 2024 or $0.46 per share compared to a net loss of approximately $4.75 million or $0.44 per share for the second quarter of 2023. For the second quarter 2024, our R&D expenses were approximately $3.9 million, up from approximately $3.6 million for the second quarter of 2023. This increase was largely driven by an increase in clinical trial activity.
我現在將分享截至 2024 年 6 月 30 日的第二季的一些財務亮點。我們的 2024 年第二季淨虧損約為 496 萬美元,即每股 0.46 美元,而 2023 年第二季的淨虧損約為 475 萬美元,即每股 0.44 美元。2024 年第二季度,我們的研發費用約為 390 萬美元,高於 2023 年第二季的約 360 萬美元。這一增長主要是由臨床試驗活動的增加所推動的。
Our general and administrative expenses for the second quarter of 2024 were approximately $1.5 million, down slightly from approximately $1.6 million for the second quarter of 2023. The decrease was primarily attributable to decreases in payroll and compensation expense and decreases in insurance expenses.
我們 2024 年第二季的一般和管理費用約為 150 萬美元,略低於 2023 年第二季的約 160 萬美元。減少的主要原因是工資和補償費用減少以及保險費用減少。
Our R&D expenses continue to exceed our G&A expenses by a strong margin, reflecting our focus on advancing our product candidates and pipeline. Our loss from operations in the second quarter of 2024 was partially offset by interest income and other income net totaling approximately $449,000 as compared to interest income and other income net totaling approximately $444,000 for the second quarter of 2023.
我們的研發費用持續大幅超過一般管理費用,反映出我們專注於推進我們的產品候選人和管道。我們 2024 年第二季的營運虧損被總計約 449,000 美元的利息收入和其他收入淨額部分抵消,而 2023 年第二季的利息收入和其他收入淨額總計約 444,000 美元。
Our cash position, which includes cash equivalents and marketable securities was approximately $33.3 million as of June 30, 2024. We anticipate this balance will provide us with a cash runway into at least Q3 of 2025.
截至 2024 年 6 月 30 日,我們的現金部位(包括現金等價物和有價證券)約為 3,330 萬美元。我們預計這一餘額將為我們提供至少到 2025 年第三季的現金跑道。
Importantly, we believe our solid financial position will fuel continued growth and evolution of our RADR AI platform and continue the advancement of our portfolio of targeted oncology drug candidates. As of June 30, 2024, we had 10,758,805 shares of common stock outstanding, so about 10.75 million shares of common stock outstanding. We had outstanding warrants to purchase 81,496 shares of common stock and outstanding options to purchase 1,063,548 shares of common stock. These warrants and options, combined with our outstanding shares of common stock, give us a total fully diluted shares outstanding of approximately $11.9 million shares as of June 30, 2024.
重要的是,我們相信我們穩健的財務狀況將推動我們 RADR AI 平台的持續成長和發展,並繼續推進我們的標靶腫瘤候選藥物組合。截至 2024 年 6 月 30 日,我們有 10,758,805 股已發行普通股,因此約有 1,075 萬股已發行普通股。我們擁有可購買 81,496 股普通股的未行使認股權證和可購買 1,063,548 股普通股的未行使選擇權。這些認股權證和選擇權,加上我們已發行的普通股,截至 2024 年 6 月 30 日,我們的完全稀釋後已發行股票總額約為 1,190 萬美元。
Our team continues to be very productive under a hybrid operating model. We currently have approximately 22 employees and 4 FTE consultants focused primarily on leading and advancing our research and drug development efforts. We see this number expanding slightly in coming quarters as we add additional experienced and talented individuals to help advance our mission.
我們的團隊在混合營運模式下持續保持高效率。我們目前擁有約 22 名員工和 4 名 FTE 顧問,主要致力於領導和推進我們的研究和藥物開發工作。隨著我們增加更多經驗豐富、才華橫溢的人員來幫助推進我們的使命,我們預計這一數字在未來幾季將略有擴大。
I'll now turn the call over to Reggie for a review of initial Phase 2 patient results and future directions for our Harmonic trial.
現在,我將把電話轉給 Reggie,以審查初步的 2 期患者結果以及我們 Harmonic 試驗的未來方向。
Reggie?
雷吉?
Reggie Ewesuedo - Vice President, Clinical Development
Reggie Ewesuedo - Vice President, Clinical Development
Thank you, David.
謝謝你,大衛。
I'll start out by reviewing the study design for the Harmonic trial. There are two stages in the Harmonic trial. Stage one is the safety leading and then the randomization and expansion stage of the study. It is worth noting at this point though that investigators are completely satisfied and aligned with this strategy because it aligns very well with current dosing intervals for the standard-of-care regimen as well as disease evaluation intervals.
我將先回顧 Harmonic 試驗的研究設計。Harmonic 試驗有兩個階段。第一階段是安全主導階段,然後是研究的隨機化和擴展階段。值得注意的是,此時研究人員完全滿意並同意這一策略,因為它與標準護理方案的當前給藥間隔以及疾病評估間隔非常吻合。
I will spend the remaining of my time really going over the data. The safety lead-in is now completed with a total of seven patients enrolled. And the preliminary data is the subject of my presentation in most of the subsequent slides. The study started with geographically dispersed sites in the United States with Dr. Treat at Fox Chase at the global lead investigator. The number of sites has now been extended to the Asia Pacific region and includes renowned investigators like Dr. Goto at the National Cancer Center Hospital in Tokyo, as well as other experienced and reputable investigators both in Japan and Taiwan. The obvious need for this expansion of sites should be pretty obvious. This is due to the fact that relatively high prevalence for the patient population in that part of the world.
我將用剩下的時間來仔細研究數據。安全導入現已完成,共有七名患者入組。初步數據是我在後續大部分投影片中演示的主題。這項研究從美國各地的不同地點開始,福克斯蔡斯公司的Treat 博士擔任全球首席研究員。目前,研究中心的數量已擴展到亞太地區,其中包括東京國家癌症中心醫院的 Goto 博士等著名研究人員,以及日本和台灣其他經驗豐富、信譽良好的研究人員。這種站點擴展的明顯需求應該是非常明顯的。這是因為世界該地區患者群體的盛行率相對較高。
So let me now present the clinical data as it relates to safety when LP-300 is combined with standard of care chemotherapy doublets.
現在讓我介紹 LP-300 與標準護理化療雙藥合併使用時與安全性相關的臨床數據。
To summarize, this safety profile is in keeping with what is expected for the standard-of-care regimen. Overall, the events observed were primarily Grade 1 or 2 adverse events. Now most of these events seen in this presentation are attributable to a single patient who entered the study with multiple co-morbidities. Of note, however, having completed this stage of the program, there were no dose-limiting toxicities, severe adverse events, or more importantly, new unexpected toxicities reported and no patient has discontinued any of the treatment due to toxicity. Now this is key to a new regimen because it speaks to the tolerability of the triplet regimen.
總而言之,這種安全性符合標準護理方案的預期。整體而言,觀察到的事件主要是 1 級或 2 級不良事件。現在,本簡報中看到的大多數事件都可歸因於一名患有多種合併症的患者進入研究。然而值得注意的是,在完成該階段的計劃後,沒有出現劑量限制性毒性、嚴重不良事件,或更重要的是,沒有報告新的意外毒性,並且沒有患者因毒性而停止任何治療。現在,這是新療法的關鍵,因為它關係到三聯療法的耐受性。
I will now hand over the presentation to Panna, the CEO, to review the key takeaways from the clinical data, and I will join him as part of that presentation.
我現在將把簡報交給執行長 Panna,以審查臨床數據的關鍵要點,我將與他一起參加該簡報。
Panna Sharma - President, Chief Executive Officer, Director
Panna Sharma - President, Chief Executive Officer, Director
Thanks, Reggie. I will now review, for everyone, the key patient characteristics and our studies endpoints. And obviously, these will remain the same as we go now from the lead-in to the expansion phase. The patients are all never smokers that have histopathological evidence of Stage 3 or 4 primary lung adenocarcinoma. They have to have TKI molecular alterations such as EGFR, MET exon 14, ROS1, BRAF, ALK, NTRK fusions, and they have to have relapsed after one or more lines of therapy with those TKIs. So obviously, these are identified TKIs, which we believe are in a small family of all the potential TKI mutations that can possibly occur. That's an important note because our drug, we believe, has effects on the TKI receptors.
謝謝,雷吉。我現在將為大家回顧關鍵的患者特徵和我們的研究終點。顯然,這些將與我們現在從導入階段到擴展階段保持不變。這些患者都是從不吸煙,且具有第 3 期或第 4 期原發性肺腺癌的組織病理學證據。他們必須有 TKI 分子改變,例如 EGFR、MET 外顯子 14、ROS1、BRAF、ALK、NTRK 融合,並且必須在接受這些 TKI 的一種或多種治療後復發。顯然,這些都是已確定的 TKI,我們相信它們屬於所有可能發生的潛在 TKI 突變的小家族。這是一個重要的說明,因為我們相信我們的藥物對 TKI 受體有影響。
The study endpoints are progression-free survival and overall survival, and we'll give you a little discussion what we've seen as benchmarks for those toward the end and the secondary endpoints, which we had some of -- some of which today are objective response rate, duration of response, and clinical benefit rate. And again, it's very surprising oftentimes those who stop responding to those TKIs, they are never smokers, actually have very poor duration of response after they go to chemo doublets, in fact, usually well under five and six months. So there's a very urgent need for targeting this population.
研究終點是無惡化存活期和總體存活期,我們將給您一些討論,我們所認為的終點和次要終點的基準是什麼,我們有一些——其中一些今天是客觀緩解率、緩解持續時間和臨床受益率。再次令人驚訝的是,那些停止對 TKI 產生反應的人,他們從不吸煙,實際上在接受化療雙藥後的反應持續時間非常短,事實上,通常遠低於五到六個月。因此,非常迫切需要針對這一人群。
Reggie, you want to talk a little bit about some of the patient highlights so far?
雷吉,您想談談迄今為止患者的一些亮點嗎?
Reggie Ewesuedo - Vice President, Clinical Development
Reggie Ewesuedo - Vice President, Clinical Development
Yes, absolutely. So maybe if we go on to the next slide, as required, what we do in clinical trials is to look at the data from different angles. The first thing we did there was to look at the spider plot, which goes over the preliminary data, but with the intent to really understand the attributes of the regimen. What you see on this slide or presentation is the onset of the clinical benefits. This is rapid, and it will appear durable. Now this is key.
是的,絕對是。因此,如果我們按照要求繼續看下一張投影片,我們在臨床試驗中所做的就是從不同角度查看數據。我們在那裡做的第一件事是查看蜘蛛圖,它回顧了初步數據,但目的是真正了解方案的屬性。您在這張投影片或簡報中看到的是臨床益處的開始。這是快速的,而且會顯得持久。現在這是關鍵。
So what we're expecting is, from the regimen, if a patient is treated within the first three cycles, if we are going to derive clinical benefit, that should be sustainable. And that's what we are beginning to observe.
因此,我們對治療方案的期望是,如果患者在前三個週期內接受治療,如果我們要獲得臨床益處,那麼這應該是可持續的。這就是我們開始觀察到的情況。
So go on to the next slide, I will look at the data from another perspective, which is the waterfall plot. Now this gives us the magnitude of the clinical benefits, and as you can see on this presentation, is quite impressive. The response is just after three cycles, and this has been seen virtually for all the patients in this cohort.
那麼繼續看下一張投影片,我將從另一個角度看數據,這就是瀑布圖。現在,這為我們帶來了巨大的臨床效益,正如您在本演示中看到的那樣,這是相當令人印象深刻的。三個週期後就出現了反應,而該隊列中的所有患者幾乎都看到了這種反應。
The emerging durability of the clinical benefits, however, is presented on the next slide, which is the swimmer's plot. So again, you begin to get a sense from this presentation that 86% disease control rate in this patient population with a 43% objective response rate, which includes one patient maintaining a 50% reduction in tumor size over 14 months. Clearly, we are encouraged by these preliminary results. We'll share the results with investigators. They all, without exception, are very encouraged with what we are seeing here with this regimen.
然而,臨床益處的新興持久性將在下一張幻燈片(即游泳者圖)中呈現。再次強調,您可以從本次演示中了解到,該患者群體的疾病控制率為 86%,客觀緩解率為 43%,其中一名患者在 14 個月內腫瘤大小保持了 50% 的縮小。顯然,我們對這些初步結果感到鼓舞。我們將與調查人員分享結果。他們無一例外都對我們在這裡看到的這種療法感到非常鼓舞。
So I'll now go on to the next slide, which talks about really the demographics of this patient. And I want to pay particular attention to where we think we're seeing this benefit in the patients. We are closely monitoring the patients, but it is very clear from this that a couple of encouraging observations while assessing the demographics on specifics.
現在我將繼續看下一張投影片,其中討論了該患者的人口統計。我想特別關注我們認為我們在患者身上看到的這種益處。我們正在密切監測患者,但從中可以清楚看出,在評估具體人口統計時,有一些令人鼓舞的觀察結果。
One, the patient population is relatively more heterogeneous. That will be the case with typical studies in this space, which tend to be restricted to one driver mutation population. Two, the tyrosine kinase receptor genomic alterations at baseline is other than EGFR or EGFR alone. So one or two patients with co-mutation at baseline. We know those patients don't tend to do well with EGFR-targeted therapies.
第一,患者群體的異質性相對較高。這一領域的典型研究就是這種情況,這些研究往往只限於一種驅動突變群體。第二,基線時酪胺酸激酶受體基因組改變不是EGFR或單獨的EGFR。因此,一兩個患者在基線時發生共突變。我們知道這些患者接受 EGFR 標靶治療後效果不佳。
But you also notice that after three cycles, the tumor response is remarkably exaggerated at metabolic lesion size, leading to a complete disappearance or resolution to normalcy in size in the case of lymph nodes. Patients with low and intermediate tumor mutational burden are deriving clinical benefit, which is very exciting to us because we believe this will pave the way for a more acceptable and adaptable biomarker selection strategy, since this assessment is already part of routine clinical practice.
但您也注意到,三個週期後,代謝病灶大小的腫瘤反應顯著放大,導致淋巴結大小完全消失或恢復正常。具有低度和中等腫瘤突變負荷的患者正在獲得臨床獲益,這對我們來說非常令人興奮,因為我們相信這將為更可接受和適應性更強的生物標誌物選擇策略鋪平道路,因為這種評估已經是常規臨床實踐的一部分。
My next slide relates to the prior lines of cancer treatment and the response we are observing so far. Looking at these data, the median number of prior lines of therapy is two, with a range of one to four. Notwithstanding, the preliminary efficacy data suggest that regardless of the number of prior lines of treatment or type of prior tyrosine kinase inhibitor treatment, LP-300 when used in combination with standard of care regimen is likely to provide clinical benefit.
我的下一張投影片涉及癌症治療的先前路線以及我們迄今為止觀察到的反應。從這些數據來看,先前治療的中位數為兩線,範圍為一到四線。儘管如此,初步療效數據表明,無論先前的治療線數或先前的酪氨酸激酶抑製劑治療類型如何,LP-300 在與標準護理方案聯合使用時都可能提供臨床益處。
Now it's important to point out that one of the patients in this cohort had already been exposed to carboplatin chemo doublet but still derive remarkable and durable response. We strongly believe that based on the mechanism of action of LP-300, what we are seeing is what we've always come to know about the drug, which is that the drug is known to re-sensitize tumor cells to the effect of chemotherapy through a mechanism where it resets during the cycle. So this is very encouraging set of data for us. And again, all the investigators, including Dr. Treat, that we'll share the data with, are very excited and we look at this as being very promising.
現在需要指出的是,該隊列中的一名患者已經接受過卡鉑化療雙藥,但仍獲得了顯著且持久的反應。我們堅信,基於 LP-300 的作用機制,我們所看到的是我們一直以來對該藥物的了解,即該藥物可以使腫瘤細胞對化療的效果重新敏感。所以這對我們來說是非常令人鼓舞的數據。再說一遍,所有研究人員,包括我們將與之分享數據的Treat博士,都非常興奮,我們認為這是非常有前途的。
Next slide. So I will just review the top part of this slide, and I will invite the CEO, Dr. Panna, to review the latter part of this slide.
下一張投影片。因此,我將只回顧這張投影片的頂部部分,我將邀請執行長 Panna 博士回顧這張投影片的後半部分。
So to summarize, we have seven patients that have been enrolled into Stage 1 or the safety lead-in phase of the study. Six out of seven patients have derived clinical benefit. Three of those are partial responders, which are really significant in magnitude of response, including very remarkable reduction in metastatic lesion sites with an average tumor size reduction of about 51%. There are three noticeable stable diseases, which have resulted in an average of about 13% size reduction.
總而言之,我們有七名患者已被納入研究的第一階段或安全導入階段。七名患者中有六名獲得了臨床效益。其中三個是部分緩解者,其緩解程度確實非常顯著,包括轉移性病灶部位非常顯著減少,平均腫瘤大小減少了約 51%。有三種明顯的穩定疾病,導致體型平均縮小約 13%。
But overall, with a clinical benefit rate of 86% and an overall response rate of 43% from this initial cohort, we believe that this is very promising. Notably from a safety perspective, there are no DLTs, no serious adverse events in excess of what one would expect from the standard-of-care chemotherapy regimen, but more importantly, no new added toxicity to the doublet regimen, which tells us very clearly that after three cycles, this is a regimen that is very tolerable and most welcome in this space.
但總體而言,該初始群組的臨床受益率為 86%,整體緩解率為 43%,我們相信這是非常有希望的。值得注意的是,從安全角度來看,沒有 DLT,沒有超出標準護理化療方案預期的嚴重不良事件,但更重要的是,雙重方案沒有新增加的毒性,這非常清楚地告訴我們經過三個週期後,這是一個在這個領域非常容易忍受和最受歡迎的治療方案。
I will hand it back to Panna to review the last part of this slide.
我會將其交還給 Panna,以審查這張投影片的最後部分。
Panna Sharma - President, Chief Executive Officer, Director
Panna Sharma - President, Chief Executive Officer, Director
Yeah. Thanks, Reggie.
是的。謝謝,雷吉。
So obviously, the key ongoing consideration is measuring for the durability of response, going forward. And that's going to be very important for us. We are considering, we believe, to file for a breakthrough therapy designation if we continue to see the types of trends that we're seeing, which again, isn't just the clinical benefit rate. But also as Reggie pointed to that, there's no increase in toxicity or adverse events, which is very important, because oftentimes in this patient group, again, you're looking some serious adverse events. And so far, we've been fortunate not to have that. But more importantly, we're not seeing any that are above the normal standard of care, which is critical.
顯然,持續考慮的關鍵是衡量未來回應的持久性。這對我們來說非常重要。我們相信,如果我們繼續看到我們所看到的趨勢類型,我們正在考慮申請突破性治療指定,這不僅僅是臨床獲益率。但也正如雷吉指出的那樣,毒性或不良事件並沒有增加,這一點非常重要,因為在這個患者群體中,您經常會看到一些嚴重的不良事件。到目前為止,我們很幸運沒有遇到這種情況。但更重要的是,我們沒有看到任何高於正常照護標準的情況,這一點至關重要。
So we believe the types of clinical benefit coupled with the safety profile that we've observed to date make us very excited to look at if the statistics continue to hold over the next few cycles to apply for breakthrough therapy designation.
因此,我們相信,臨床獲益的類型加上我們迄今為止觀察到的安全性概況,讓我們非常興奮地觀察統計數據是否在接下來的幾個週期中繼續保持不變,以申請突破性治療指定。
We've also observed, which is very important to note, this has been hypothesized early on and we're beginning to see some good data is that tumor mutation burden or TMB levels that are measured as either low or intermediate are responsive to this therapy triplet. And these are typically patients that are not responsive to immunotherapies or checkpoint inhibitors. Usually high TMB or high PD-L1 is associated with the improved response to PD-L and PD-L1.
我們還觀察到,值得注意的是,這一點很早就被假設了,我們開始看到一些好的數據,即腫瘤突變負荷或測量為低或中等的 TMB 水平對這種療法有反應三聯體。這些通常是對免疫療法或檢查點抑制劑沒有反應的患者。通常,高 TMB 或高 PD-L1 與 PD-L 和 PD-L1 反應的改善有關。
So all signs point to that we really need to accelerate the enrollment in this trial, and we've begun sharing the observations to date with the sites and with our Asian colleagues and that we believe we'll be able to get to some significant enrollment over the next several months as a trial now goes into the expansion phase.
因此,所有跡像都表明,我們確實需要加快這項試驗的註冊,我們已經開始與這些網站和我們的亞洲同事分享迄今為止的觀察結果,我們相信我們將能夠實現一些重大的註冊在接下來的幾個月裡,試驗現在進入了擴展階段。
Let's go in the next slide, please.
請讓我們看下一張投影片。
Reggie Ewesuedo - Vice President, Clinical Development
Reggie Ewesuedo - Vice President, Clinical Development
So let me conclude my part of the presentation, and to put the Harmony trial in context, I think there's several studies you see on this slide pertaining to the impact or lack thereof of immunotherapy in the never-smoker population, which is the population targeted here. The never smokers with advanced lung adenocarcinoma clearly do not respond well to immunotherapy either when used alone or in combination with standard-of-care carboplatin doublet.
因此,讓我結束我的簡報部分,並將Harmony 試驗放在背景中,我認為您在這張投影片上看到了幾項研究,涉及免疫療法對從不吸菸人群(即目標人群)的影響或缺乏。患有晚期肺腺癌的從不吸菸者顯然對免疫療法的反應不佳,無論是單獨使用還是與標準護理卡鉑雙聯療法合併使用。
However, the preliminary profile and activity we have seen in this study would seem to suggest that this subgroup of patients would tend to have low or intermediate tumor mutational burden will potentially benefit from this Harmonic trial regimen. This study is currently enrolling in the randomization and expansion phase, and as Panna pointed out, more data in the near future to further define and/or validate the clinical activity that we've observed so far.
然而,我們在本研究中看到的初步概況和活動似乎表明,該亞組患者往往具有低或中等腫瘤突變負擔,可能會從這種 Harmonic 試驗方案中受益。這項研究目前正處於隨機化和擴展階段,正如 Panna 所指出的那樣,在不久的將來將有更多數據來進一步定義和/或驗證我們迄今為止觀察到的臨床活動。
Could you go on to the next slide, please? This just summarizes, at a very high level, the key highlights about LP-300. There were previous studies. This led down to scientific rationale for the current design, where we saw very impressive improvement in clinical benefit in terms of survival when we looked at never smokers versus smokers. So that was the scientific basis for using LP-300 in combination with the current doublet standard of care. The mechanism of action are reflected on this slide.
您可以繼續看下一張投影片嗎?這只是在非常高的水平上總結了 LP-300 的主要亮點。之前有研究。這引出了目前設計的科學原理,當我們觀察從不吸菸者與吸菸者的情況時,我們發現在生存方面的臨床效益有了非常令人印象深刻的改善。這就是將 LP-300 與目前雙重護理標準結合使用的科學基礎。這張投影片反映了作用機制。
But one thing that is very fundamental in terms of the regimen which we are beginning to observe is that well over 1,000 patients have been dosed with this drug, either alone, even in healthy volunteers, or in combination with different chemotherapy regimens. So the safety profile is well established. No surprise from the study that we have currently and is welcomed by all the investigators as we have looked at the first cohort of patients from a safety and tolerability perspective. I just thought I should share with you all the comparative data, the historical benchmark for what we are talking about.
但就我們開始觀察到的治療方案而言,非常重要的一件事是,已經有超過 1,000 名患者單獨服用了這種藥物,甚至是在健康志願者中,或與不同的化療方案結合使用。因此,安全性已得到很好的確立。我們目前進行的這項研究並不令人意外,並且受到所有研究人員的歡迎,因為我們從安全性和耐受性的角度研究了第一批患者。我只是想我應該與大家分享所有的比較數據,也就是我們正在談論的歷史基準。
The next phase of this study, obviously, is combining LP-300 plus the pemetrexed and carboplatin doublet versus carboplatin pemetrexed doublet. Now this is the benchmark. When you look at overall response rate in these studies, you're going anywhere from about 26% to probably on the very high end, recently with the MARIPOSA-2 study, about 36%.
顯然,這項研究的下一階段是將 LP-300 加培美曲塞和卡鉑雙藥與卡鉑培美曲塞雙藥結合。現在這是基準。當您查看這些研究中的整體回應率時,您會發現從大約 26% 到可能非常高,最近的 MARIPOSA-2 研究約為 36%。
Right now, with the data that we have, sharing -- this is the opinion of the investigators. We are clearly above what this historical data is and I think we can attest to that. But more importantly, as the data matures, we are keen on understanding the median duration of response as well as the PFS, which obviously is the primary endpoint of this study, a co-primary endpoint with survival. But all the studies, either with IO agents or bispecifics, as you look at these particular standard-of-care regimen, right now, preliminary data obviously is looking better than what has been known in this space.
現在,根據我們所掌握的數據,這是研究人員的意見。我們顯然高於歷史數據,我認為我們可以證明這一點。但更重要的是,隨著數據的成熟,我們熱衷於了解中位緩解持續時間以及 PFS,這顯然是本研究的主要終點,是與存活期共同的主要終點。但所有的研究,無論是 IO 製劑還是雙特異性藥物,當你觀察這些特定的護理標準方案時,現在的初步數據顯然比該領域已知的數據要好。
So I will conclude by saying that the data that we have, the clinical data from assisted safety perspective is spot-on. It's on standard-of-care regimen and expected safety profile. And in terms of the preliminary an emerging clinical efficacy profile, I think, we're encouraged by what we're seeing. Thank you.
因此,我最後想說的是,我們所掌握的數據,從輔助安全角度來看的臨床數據是準確的。它符合標準護理方案和預期安全狀況。我認為,就初步的新興臨床療效概況而言,我們對所看到的情況感到鼓舞。謝謝。
Panna Sharma - President, Chief Executive Officer, Director
Panna Sharma - President, Chief Executive Officer, Director
Well, Reggie, thank you, and thank you to our clinical colleagues, and of course, patients for the first phase.
好吧,雷吉,謝謝你,也感謝我們的臨床同事,當然還有第一階段的病人。
Moving back to the other aspects of our portfolio and people are very excited about Starlight. We've seen some really good movement this year in brain cancers. Obviously, initially in pediatric brain cancers with the results from Day One pharmaceutical and now more recently with the result in IDH mutant gliomas.
回到我們產品組合的其他方面,人們對星光感到非常興奮。今年我們在腦癌方面看到了一些非常好的進展。顯然,最初是針對兒童腦癌,Day One 製藥公司的結果是,現在是 IDH 突變神經膠質瘤的結果。
And so it's an exciting time. And I think as we've stated before, we want to further monetize Starlight because Starlight is pointed at some very important and significant indications. We've now started site selection for the upcoming Phase 1b and 2 trials. We'll make several announcements in the coming months and the progress on those fronts and also on additional talent and leadership that we plan on leveraging at Starlight.
所以這是一個令人興奮的時刻。我認為正如我們之前所說,我們希望進一步將星光貨幣化,因為星光指向了一些非常重要且有意義的跡象。我們現在已經開始為即將到來的 1b 期和 2 期試驗選址。我們將在未來幾個月內發布幾項公告,以及這些方面的進展,以及我們計劃在星光公司利用的額外人才和領導力。
For those who have not listened in on the backdrop of Starlight or on the details of the trials, we have some webinars that we invite you to listen to. Additionally, a major part of our business, obviously, is to inform, educate, and share with the general public and investors and the oncology community the details of our programs and our efforts. So last Wednesday of every month, we'll focus on our trials, our publications, our collaborations, and our AI developments. Our next webinar will be the end of this month, August 28, on Wednesday, where Reggie will dive deeper into some of the data and clinical readouts. And that will be followed up additional data from our AI platform in September and some insights about our efforts in immuno-oncology with 184 in September. So all very, very relevant.
對於那些還沒有聽過星光號背景或試驗細節的人,我們邀請您收聽一些網路研討會。此外,顯然,我們業務的一個主要部分是向公眾、投資者和腫瘤學界通報、教育和分享我們的計劃和努力的細節。因此,每個月的最後一個星期三,我們將專注於我們的試驗、出版物、合作和人工智慧開發。我們的下一次網路研討會將於本月底,即 8 月 28 日星期三舉行,雷吉將深入探討一些數據和臨床讀數。接下來我們將在 9 月從我們的人工智慧平台獲得更多數據,並在 9 月與 184 合作,以了解我們在免疫腫瘤學方面的工作的一些見解。所以一切都非常非常相關。
We've also had additional publications highlighting the clinical value of our RADR work. We had a great publication that showed the potential for LP-184 to be synergistic with PARP inhibitors in a wide range of solid tumors. This is published at AACR Journal's Cancer Research Communications. And again, this is in a wide range of solid tumors that are what's called HRD, homologous repair deficient. And this is a very under addressed large category that's generating billions in drug sales annually.
我們也發表了其他出版物,強調了我們 RADR 工作的臨床價值。我們發表了一篇出色的出版物,展示了 LP-184 在多種實體瘤中與 PARP 抑制劑具有協同作用的潛力。本文發表在 AACR 期刊的癌症研究通訊。再說一次,這種情況發生在多種實體腫瘤中,即所謂的 HRD(同源修復缺陷)。這是一個很少被重視的大類別,每年產生數十億美元的藥品銷售額。
The preclinical findings in the paper illustrate the potential of LP-184 to be a pan-HRD cancer therapeutic which could be the first drug of this type in this class. So it's a really great observation and will, we believe, help us establish a combination trial in this group of patients once we've established the MTD in the Phase 1a for LP-184.
論文中的臨床前研究結果說明了 LP-184 作為泛 HRD 癌症治療藥物的潛力,這可能是此類藥物中的第一個此類藥物。因此,這是一次非常好的觀察,我們相信,一旦我們確定了 LP-184 1a 期的 MTD,它將幫助我們在這群患者中建立聯合試驗。
Also, as we communicated yesterday, we have new data and scientific findings conducted in conjunction with Dr. Young Doo and Phoebus Lin at MD Anderson. And these were presented at the Immuno-Oncology Summit just yesterday by our colleague. And these findings showcase what Lantern believes would be the role of LP-184 to be combined with checkpoint inhibitors to provide greater response in triple negative breast cancer due to the synergy, but also we believe because of the mechanism where LP-184 can transform triple negative breast cancer tumors that are unresponsive or what's called cold to responsive or hot to checkpoint inhibitors.
此外,正如我們昨天所傳達的,我們與 MD 安德森的 Young Doo 博士和 Phoebus Lin 合作獲得了新的數據和科學發現。我們的同事昨天在免疫腫瘤學高峰會上介紹了這些內容。這些發現展示了Lantern 認為LP-184 與檢查點抑制劑聯合使用的作用,由於協同作用,可以在三陰性乳癌中提供更大的反應,但我們也相信,因為LP-184 可以轉化三陰性乳腺癌的機轉對檢查點抑制劑無反應或所謂的冷反應或熱反應的陰性乳癌腫瘤。
And we believe that it reshapes the tumor microenvironment, both through heightened T-cell aggregation and also by decreasing M2 macrophages. Both are really, really critical in heightening on the potential for IO therapies to work. The poster can be found on our website under our posters section.
我們相信它透過增強 T 細胞聚集和減少 M2 巨噬細胞來重塑腫瘤微環境。兩者對於提高 IO 療法的工作潛力都非常非常關鍵。該海報可以在我們網站的海報部分找到。
2024 has emerged to be a year of progress for us where we've accelerated ideas and AI-driven insights now into the clinic. And these insights are now not just good publications and great theory, but they're impacting patients in their journey to fight cancer and also influencing the development decisions of other people in the cancer category. I think our collective efforts and dedication have fostered a transformational shift, not only for our company but actually for groups of our industry. And that's setting us on a very exciting trajectory where we can not only improve the lives of cancer patients but also do it in ways that is more effective and more scalable. We believe that our business model will drive affordable, more personalized treatment options in cancer.
2024 年對我們來說是進步的一年,我們加快了將想法和人工智慧驅動的見解帶入臨床的步伐。這些見解現在不僅是好的出版物和偉大的理論,而且還影響患者對抗癌症的旅程,也影響癌症領域其他人的開發決策。我認為,我們的集體努力和奉獻精神促進了變革,不僅對我們公司而言,實際上對我們行業的團體也是如此。這使我們走上了一條非常令人興奮的軌道,我們不僅可以改善癌症患者的生活,而且可以以更有效、更可擴展的方式做到這一點。我們相信,我們的商業模式將推動癌症領域價格實惠、更個人化的治療選擇。
Now that, I'd like to now open the call to any questions or clarifications.
現在,我想開始電話詢問任何問題或澄清。
Panna Sharma - President, Chief Executive Officer, Director
Panna Sharma - President, Chief Executive Officer, Director
(Event Instructions) So before I get into questions, I'd like to take a moment to personally thank our team for helping to prepare us for these calls. And to gather all this takes a lot of work. So thank you for our team for taking time out of their normal day-to-day to help make this happen.
(活動說明)因此,在提出問題之前,我想花點時間親自感謝我們的團隊幫助我們為這些電話做好準備。收集所有這些需要大量的工作。感謝我們的團隊在日常工作中抽出時間來幫助實現這一目標。
Keay, Chardan. I think you're muted, Keay.
基伊,查丹。我覺得你很沉默,基伊。
John.
約翰.
Unidentified Participant
Unidentified Participant
Hello. I thought I'd start with a question on just what kind of threshold you're looking for that shows LP-300 [merits] a breakthrough candidacy status.
你好。我想我應該先問一個問題,即您正在尋找什麼樣的門檻來顯示 LP-300 [值得]突破性的候選地位。
Panna Sharma - President, Chief Executive Officer, Director
Panna Sharma - President, Chief Executive Officer, Director
I think if we see the current trajectory in the next, let's say, 12 to 20 patients plus we get some durability data, I think that would give us comfort level. But we'd have to see the totality of the data. Seven patients is a good start, but it's preliminary. We'd love to see 21 patients. We had 14 patients at a 21, that would give us a lot -- gets us pretty excited -- 16 patients, I mean, but the overall clinical benefit rate of 86% is largely unheard of in this group. So we want to make sure that's durable. And so more patients, drive the end number, and then, some durability of response, which I'm sure the FDA will want to look at for breakthrough.
我認為,如果我們看到接下來的當前軌跡,比如說 12 到 20 名患者,再加上我們獲得一些耐久性數據,我認為這會為我們帶來舒適度。但我們必須查看數據的全部。七名患者是一個好的開始,但這只是初步的。我們很樂意見到 21 位患者。我們有14 名21 歲的患者,這會給我們帶來很多——讓我們非常興奮——我的意思是16 名患者,但86% 的總體臨床受益率在這一組中基本上是聞所未聞的。所以我們要確保它是耐用的。更多的患者,推動最終數字,然後,一些反應的持久性,我相信 FDA 會希望尋求突破。
Unidentified Participant
Unidentified Participant
Okay. So about a two-thirds clinical benefit rate is kind of what you'd be looking for?
好的。那麼大約三分之二的臨床受益率正是您想要的?
Panna Sharma - President, Chief Executive Officer, Director
Panna Sharma - President, Chief Executive Officer, Director
That's probably -- Yeah, that's kind of [getting]. We have to take a look at the totality of the data, but yes, I mean, the metastatic lesion improvement, no safety issues, those all skew us towards some positive as well, right?
這可能是——是的,這有點像[得到]。我們必須看一下數據的整體性,但是,是的,我的意思是,轉移性病變的改善,沒有安全問題,這些都讓我們傾向於一些積極的方面,對吧?
Unidentified Participant
Unidentified Participant
And then looking at the safety profile that you've seen in the first seven Harmonic patients and comparing it to some of the other NSCLC populations that were using EGFR TKIs and checkpoint inhibitors, kind of how does that safety profile compare to some of those other molecules out there or biologics out there?
然後查看您在前 7 名 Harmonic 患者中看到的安全性概況,並將其與使用 EGFR TKI 和檢查點抑制劑的其他一些 NSCLC 人群進行比較,該安全性概況與其他一些患者相比有何不同分子還是生物製劑?
Panna Sharma - President, Chief Executive Officer, Director
Panna Sharma - President, Chief Executive Officer, Director
Well, let our safety expert, Reggie, take that question on.
好吧,讓我們的安全專家雷吉回答這個問題。
Unidentified Participant
Unidentified Participant
Hi, Reggie.
嗨,雷吉。
Reggie Ewesuedo - Vice President, Clinical Development
Reggie Ewesuedo - Vice President, Clinical Development
Hi, John. No, that's a very good question. I would just tell you off the bat, what is unheard of in this space is for patients to go on to about 9 weeks or 9 to 10 weeks of treatment with any kind of dose interruption or discontinuation of the regimen. I mean, that is very common with the TKIs in combination. You can look at the current MARIPOS-2 trial, for example, which is the most recent with the bispecific combination, with the TKI, by the way, for patients in the same population versus the same standard of care. It shouldn't surprise anybody in this field to know that certainly up to 80% of the patients discontinued treatment for one reason or the other because of toxicities, that they had to interrupt treatment. And furthermore, those patients literally discontinue treatment.
嗨,約翰。不,這是一個很好的問題。我只想告訴你,在這個領域聞所未聞的是,患者會繼續接受大約 9 週或 9 至 10 週的治療,並伴隨任何形式的劑量中斷或中止治療方案。我的意思是,這在 TKI 組合中很常見。例如,您可以查看目前的 MARIPOS-2 試驗,這是最新的雙特異性組合試驗,順便說一句,針對相同人群中的患者以及相同的護理標準。這一領域的任何人都不應該感到驚訝,因為肯定有多達 80% 的患者因毒性而停止治療,他們不得不中斷治療。此外,這些患者實際上停止了治療。
So this again, presenting this preliminary safety data with no new toxicity to these investigators was really exciting because for this length of time, none of the patients required dose discontinuation for any of the -- certainly not LP-300.
因此,再次向這些研究人員提供沒有新毒性的初步安全數據確實令人興奮,因為在這麼長的時間內,沒有患者需要停止服用任何藥物——當然不是 LP-300。
Unidentified Participant
Unidentified Participant
Okay, great. And just one more question on your collaborations. When you look at the Oregon Therapeutics and also Actuate and TTC, how will you determine if this is a success? I mean, what kind of milestones you're looking for kind of internally to show that these are kind of working and they're valuable.
好的,太好了。還有一個關於你們合作的問題。當您查看 Oregon Therapeutics、Actuate 和 TTC 時,您將如何確定這是否成功?我的意思是,你在內部尋找什麼樣的里程碑來表明這些是有效的並且是有價值的。
Panna Sharma - President, Chief Executive Officer, Director
Panna Sharma - President, Chief Executive Officer, Director
Yeah, each one is different -- I'll take that question -- unique. I mean, Actuate has filed an S1. And I think that the work our team did was definitely helpful for them in terms of understanding their patient population and developing some specific insights related to people who were refractory to PD-1 therapy that would have potential to benefit from their drug, elraglusib. Yeah, hard to say.
是的,每個人都是不同的——我會回答這個問題——都是獨一無二的。我的意思是,Actuate 已提交 S1。我認為我們團隊所做的工作絕對對他們有幫助,幫助他們了解患者群體,並針對那些對 PD-1 療法抗藥性的人形成一些具體見解,這些人有可能從他們的藥物 elraglusib 中受益。是的,很難說。
So we think it's -- we think that's on track to be successful because we've helped the company. And if they do go public and are able to raise additional capital, we. Definitely think it's because of the focus around understanding the patient profile.
所以我們認為,我們認為這將會成功,因為我們幫助了該公司。如果他們確實上市並能夠籌集更多資金,我們。肯定認為是因為重點了解患者概況。
With regards to TTC, that's -- they come a little after. So that one, we're still working. We do have some very good ideas. TTC is out raising capital or looking for grant money for the next phase. But that one is not as well capitalized as Actuate has been. So they're slower.
至於 TTC,他們晚了一點。所以,我們仍在努力。我們確實有一些非常好的想法。TTC 正在為下一階段籌集資金或尋找贈款。但該公司的資本並不像 Actuate 那麼足夠。所以他們比較慢。
Oregon is the newest one. And I already -- I'm pretty excited about what we're doing for Oregon. And it's not -- it's barely two months old, so it's very early, but we have some very clear milestones in terms of developing some collaborative IP together that we can monetize, specifically helping them define combinations and define indications that they haven't thought of. And I think we'll be able to accomplish that.
俄勒岡州是最新的一個。我已經對我們為俄勒岡州所做的事情感到非常興奮。事實並非如此——它才剛剛兩個月,所以還很早,但我們在共同開發一些協作知識產權方面有一些非常明確的里程碑,我們可以將其貨幣化,特別是幫助他們定義組合併定義他們沒有想到的跡象的。我認為我們能夠實現這一目標。
Eventually, the IP has to be monetized for it to be success for everyone. But you got to have good strong and valid ideas and do them inexpensively, which part of the magic of AI.
最終,智慧財產權必須貨幣化才能為每個人帶來成功。但你必須擁有強大而有效的想法,並以低廉的成本實現它們,這就是人工智慧的魔力之一。
David Margrave - Chief Financial Officer, Secretary
David Margrave - Chief Financial Officer, Secretary
Yeah, and just adding very quickly to that, John, in simple terms, I think it's the question of are we able to allow them to see things and do things that they wouldn't be able to do otherwise. And this goes beyond our collaborations in terms of RADR and AI. And we're seeing just more and more evidence in these collaborations and other ways that's showing insights that wouldn't have arisen without that additional insight.
是的,約翰,簡單地說,我認為問題是我們是否能夠讓他們看到事物並做他們本來無法做的事情。這超出了我們在 RADR 和人工智慧方面的合作範圍。我們在這些合作和其他方式中看到越來越多的證據,這些證據顯示出如果沒有額外的洞察力就不會出現的洞察力。
Panna Sharma - President, Chief Executive Officer, Director
Panna Sharma - President, Chief Executive Officer, Director
Keay.
基伊。
Unidentified Participant
Unidentified Participant
Yeah, it's Keay at Chardan. Appreciate all the detailed patient data. I guess the first question is, again, with the huge caveat, this is small numbers. But the patient with the RET mutations had a nice response. Not sure if they were recharged with (inaudible) but was that a surprise to you based on your pre-clin data?
是的,這是查丹的基伊。欣賞所有詳細的患者數據。我想第一個問題是,再次強調,這是一個很小的數字。但攜帶 RET 突變的患者反應良好。不確定它們是否已充電(聽不清楚),但根據您的臨床前數據,您是否感到驚訝?
Reggie Ewesuedo - Vice President, Clinical Development
Reggie Ewesuedo - Vice President, Clinical Development
Maybe I'll take that one. It wasn't really a surprise because, again, if you -- maybe one of the highlights for LP-300, what we understand or the mechanism of action, one of the set of data we've been able to generate preclinically is understanding that the drug really binds to cystine residues of different tyrosine kinase receptors, including RET. So seeing this kind of clinical data is very exciting to us. And that's why in the presentation, I made sure to emphasize that it's not just a driver mutation of interest as you see in other clinical trials in this space. But rather the protocol is designed to really capture any driver mutations for those patients to come in as far as they are never smokers. So this is very encouraging for us. It didn't come as a surprise.
也許我會選擇那個。這並不令人意外,因為,如果您——也許是 LP-300 的亮點之一,我們所理解的內容或作用機制,我們能夠在臨床前生成的一組數據之一就是理解該藥物確實與不同酪胺酸激酶受體(包括RET)的胱胺酸殘基結合。所以看到這樣的臨床數據對我們來說是非常令人興奮的。這就是為什麼在演示中,我確保強調它不僅僅是您在該領域的其他臨床試驗中看到的感興趣的驅動突變。相反,該方案的目的是真正捕獲那些從不吸煙的患者的任何驅動突變。所以這對我們來說是非常鼓舞人心的。這並不令人意外。
Unidentified Participant
Unidentified Participant
And then with respect to patient 107002 who had progressive disease, anything about their baseline that may be -- might have predicted a less than favorable response there?
然後,對於患有疾病進展的患者 107002,他們的基線是否可能預測出不太有利的反應?
Reggie Ewesuedo - Vice President, Clinical Development
Reggie Ewesuedo - Vice President, Clinical Development
This was the first patient enrolled in the trial. A lot of things going on with the protocol at that time. But this patient really accounted for most of the toxicities you've seen because of co-morbidities. So the patient, one would say, wasn't an ideal patient for a clinical trial.
這是第一位參加該試驗的患者。當時協議發生了很多事情。但這位患者確實是您所見過的大多數因合併症而引起的毒性反應的原因。因此有人會說,這名患者並不是臨床試驗的理想患者。
Panna Sharma - President, Chief Executive Officer, Director
Panna Sharma - President, Chief Executive Officer, Director
We have a question in the chat window that I'm going to go ahead and answer. I'll read it out for everyone.
我們在聊天視窗中有一個問題,我將繼續回答。我給大家讀一下。
Can you please go deeper into checkpoint inhibitors and the market they currently garner, specifically KEYTRUDA and why LP-184 maybe a great and synergistic partner?
您能否更深入地了解檢查點抑制劑及其目前所佔據的市場,特別是 KEYTRUDA,以及為什麼 LP-184 可能是一個出色的協同合作夥伴?
Good question. Now, I'm not a KEYTRUDA rep or I'm not a Merck rep but having done a lot of work for Merck in my prior career, I can tell you that the 57-patient trial that they had got them on the map. Had remarkable results. The market today for checkpoint inhibitors, including KEYTRUDA, is somewhere close to $42 billion to $48 billion. So it's a significant market.
好問題。現在,我不是 KEYTRUDA 代表,也不是默克代表,但在我之前的職業生涯中為默克做了很多工作,我可以告訴你,他們已經讓他們在地圖上獲得了 57 名患者的試驗。取得了顯著的成果。目前,包括 KEYTRUDA 在內的檢查點抑制劑市場規模接近 420 億至 480 億美元。所以這是一個重要的市場。
Now, we all know that KEYTRUDA has -- these early-stage PD-L1s are coming off market. There's some new PD-L1s already out or PD-1s. Coherus has one of those already out, I believe, that's biosimilar. Pricing isn't great, but I've heard that the efficacy is very, very good. It's clean biosimilar.
現在,我們都知道 KEYTRUDA 已經——這些早期階段的 PD-L1 即將退出市場。一些新的 PD-L1 或 PD-1 已經上市。我相信 Coherus 已經推出了其中一種產品,那就是生物相似藥。價格雖然不高,但是聽說效果非常非常好。它是乾淨的生物相似藥。
So the market, I think, will remain fairly robust. Analyst project that it will grow about 15% to 17% because there's a whole new wave of new checkpoint inhibitors. So it's a good market. Now we're not going after that whole market. We're going after is we believe that there's even a larger group of patients that don't respond to checkpoint inhibitors that could benefit from them.
因此,我認為市場將保持相當強勁。分析師預計,由於新一波新的檢查點抑制劑的出現,這一數字將增加約 15% 至 17%。所以這是一個很好的市場。現在我們不會追求整個市場。我們相信,甚至有更多的患者對檢查點抑制劑沒有反應,但他們可以從中受益。
And there's a whole group of people whose lives have been wonderfully prolonged, but their cancer is not cured. So they stop responding to checkpoint inhibitors and the tumor microenvironment reshapes itself. So that's where LP-184, we believe, can be a great and synergistic partner. The first one, of course, we have some data on, that we're excited about, is in triple negative breast cancer. And triple negative breast cancer can be rapidly evolving in terms of its clonal evolution. So that's also part of the reason why we good to go after. And so we think that TNBC would be a great initial target to get early -- an early win, and then potentially, go after other places where checkpoint inhibitors can be improved, which will be many of those tumors where you have complex tumor microenvironments and you have a rapid clonal evolution.
還有一群人的生命得到了驚人的延長,但他們的癌症卻沒有被治癒。因此,它們停止對檢查點抑制劑做出反應,腫瘤微環境會自我重塑。因此,我們相信 LP-184 可以成為一個出色的協同合作夥伴。當然,我們有一些令人興奮的數據,第一個是三陰性乳癌。三陰性乳癌的克隆進化可能會迅速發展。所以這也是我們願意追求的部分原因。因此,我們認為 TNBC 將是一個很好的早期目標——早期勝利,然後有可能去尋找其他可以改進檢查點抑製劑的地方,這將是許多具有復雜腫瘤微環境和你有一個快速的克隆進化。
And so that to me can be multiple, multiple billions of dollars of potential over time. But the key is to pick one where we know that we can have a good effect and potential win and TNBC looks like one where we've seen synergy. We've demonstrated clinical evidence. We see two of the most important hallmarks. One is we're bringing and recruiting the right kind of T cell environment, and we're also decreasing the number of M2 macrophages, both which had been very, very correlated with reducing response to immunotherapies.
因此,對我來說,隨著時間的推移,這可能會帶來數十億美元的潛力。但關鍵是選擇一個我們知道可以產生良好效果和潛在勝利的公司,而 TNBC 看起來像我們已經看到協同效應的公司。我們已經證明了臨床證據。我們看到兩個最重要的標誌。一是我們正在引入和招募正確的 T 細胞環境,同時我們也在減少 M2 巨噬細胞的數量,這兩者都與減少免疫療法的反應非常非常相關。
Thank you for that question, John.
謝謝你提出這個問題,約翰。
I think, the another question in the chat window that just popped up. Michael, is that right? Yeah. Michael's question, I'll read, is are you open to small pharma partnership opportunities?
我想,剛才彈出的聊天視窗中的另一個問題。邁克爾,是嗎?是的。我會讀一下邁克爾的問題,您是否願意接受小型製藥公司的合作機會?
Well, Michael, being a small pharma ourselves, yeah, absolutely. Yes, we're a small biopharma that acts like a big pharma. But we are a small pharma. I mean, we're very -- we're always looking for partnership opportunities and welcome you to send myself or members that you know in the company. An e-mail, and we will get back to you quickly.
好吧,邁克爾,我們自己就是一家小型製藥公司,是的,絕對是。是的,我們是一家小型生物製藥公司,但其運作方式就像一家大型製藥公司。但我們是一家小型製藥公司。我的意思是,我們一直在尋找合作機會,並歡迎您派遣我自己或您在公司認識的成員。發送電子郵件,我們會盡快回覆您。
I have time for one more question. I don't know if there's any more questions. There's one more question. So I'll go ahead and take this one. The question is given the market cap of the company, do you think Lantern is still relevant to be a major player in the industry?
我還有時間再問一個問題。不知道還有沒有問題。還有一個問題。所以我會繼續接受這個。問題是考慮到該公司的市值,您認為 Lantern 仍然有必要成為該行業的主要參與者嗎?
That's a great -- it's a good fundamental question as an investor, I think. So thank you for being involved. I think there's room for big companies and small. And I would like to urge everyone that with the exception of a few handful of companies, every big company started small. Except Lab Core, which started because of Roche and US Labs. But I mean, even Regeneron and Biogen. Now is that what we're going to be in the future? Who knows. But I do think that very likely that our approach and our drugs will be partnered, licensed, and sold. That's what we're doing. Or we'll spin out the assets.
我認為,作為投資者,這是一個很好的基本問題。所以感謝您的參與。我認為大公司和小公司都有空間。我想提醒大家,除了極少數公司之外,每家大公司都是從小做起的。除了Lab Core,它是因為羅氏和美國實驗室而開始的。但我的意思是,甚至是再生元(Regeneron)和百健(Biogen)。現在這就是我們未來的樣子嗎?誰知道呢。但我確實認為我們的方法和我們的藥物很可能會合作、授權和銷售。這就是我們正在做的事情。或者我們將剝離資產。
So I think that we are very relevant to the industry. And I've seen a lot of companies trying to copycat our approach. A lot of companies are very interested. So I think we will be very relevant. And I think you will see ups and downs in this industry, just like every other industry. I'd like to remind people that even Amazon before became a huge behemoth -- not that we're going to become Amazon -- saw 80 % and 90% reductions in stock price about four or five times during on their way up.
所以我認為我們與這個行業非常相關。我看到很多公司試圖模仿我們的方法。很多公司都非常感興趣。所以我認為我們將會非常相關。我認為你會看到這個行業的起起落落,就像其他行業一樣。我想提醒人們的是,即使亞馬遜在成為一個巨大的龐然大物之前——並不是說我們將成為亞馬遜——股價在上漲過程中也下跌了 80% 和 90% 大約四到五倍。
So stock prices and everything, I think it's a huge indicator of how much of your cost of capital will be. But I think we're probably the cheapest company with a Phase 2 drug and two Phase 1 drugs that are first in class. So that does get me, at times, concerned and frustrated, but -- and we're not spending $60 million to $80 million a quarter like some other companies who are in the press today for their merger.
因此,股票價格和其他一切,我認為它是衡量資本成本多少的重要指標。但我認為我們可能是最便宜的公司,擁有一種二期藥物和兩種一流的一期藥物。因此,這有時確實讓我感到擔憂和沮喪,但是 - 我們並沒有像今天在媒體上報道的其他一些公司那樣,每個季度花費 6000 萬到 8000 萬美元進行合併。
So it's -- you got to do things differently, but you also really have to think about how to do them differently. You can't say you're going to use AI and then spend like Eli Lilly or Roche. So I think we can do things different with AI. Pick the right kind of very select focused bets and opportunities and try to develop is with a tremendous amount of operational efficiency. And so I think that will pay a lot of dividends to our investors, but also, will allow us to be very relevant in the industry.
所以,你必須以不同的方式做事,但你也必須真正考慮如何以不同的方式做事。你不能說你要使用人工智慧,然後像禮來公司或羅氏公司那樣花錢。所以我認為我們可以用人工智慧做一些不同的事情。選擇正確的、高度集中的賭注和機會,並嘗試以巨大的營運效率進行開發。因此,我認為這將為我們的投資者帶來大量紅利,同時也將使我們在行業中具有非常重要的影響力。
David Margrave - Chief Financial Officer, Secretary
David Margrave - Chief Financial Officer, Secretary
And just adding to that very quickly, we are beginning to see some great momentum on multiple fronts. We talked a lot today about Harmonic, but there are some very exciting things going on with our other candidates as well, and then, RADR in addition to that. So we're building some great momentum that we think will be value driving in multiple ways.
而且很快,我們開始在多個方面看到一些巨大的勢頭。今天我們談了很多關於 Harmonic 的事情,但我們的其他候選人也發生了一些非常令人興奮的事情,除此之外,還有 RADR。因此,我們正在建立一些強大的勢頭,我們認為這將在多種方面推動價值。
Panna Sharma - President, Chief Executive Officer, Director
Panna Sharma - President, Chief Executive Officer, Director
Thank you. So in closing, I want to express my thanks and gratitude to our team, our partners, our stakeholders and those who are following the company for their support and interest. Together, I think we are really lighting the way toward a brighter future in oncology and solving real world problems for patients with proprietary AI solutions and insight. And we think we're going to radically alter the potential to change the cost structure and timelines in drug discovery.
謝謝。最後,我想對我們的團隊、合作夥伴、利害關係人以及關注公司的支持和關注的人們表示感謝和感謝。我認為,我們確實正在為腫瘤學開闢更光明的未來,並透過專有的人工智慧解決方案和洞察力為患者解決現實世界的問題。我們認為我們將從根本上改變藥物發現成本結構和時間表的潛力。
So thank you, everyone, for your time this afternoon. With that, I'd like to adjourn the call today.
謝謝大家今天下午抽出時間。因此,我想暫停今天的通話。
David Margrave - Chief Financial Officer, Secretary
David Margrave - Chief Financial Officer, Secretary
Thanks a lot.
多謝。
Panna Sharma - President, Chief Executive Officer, Director
Panna Sharma - President, Chief Executive Officer, Director
Thank you.
謝謝。